JP2022540178A - Fluid collection device, system and method - Google Patents

Abstract

Examples relate to devices, systems and methods for collection of fluids such as urine. The fluid collection device is shaped to complement the female anatomy or the male anatomy near the urethra. The fluid impermeable coating of the fluid collection device is sized and shaped to provide the fluid collection device with a soft, smooth, compliant outer surface. A fluid collector may be coupled to the vacuum source via one or more sections of the conduit.

Description

(Cross reference to related applications)
This application claims priority to U.S. Patent Application No. 62/873,045, filed July 11, 2019, the disclosure of which is hereby incorporated by reference in its entirety.

Individuals may have limited or impaired mobility that makes the normal voiding process difficult or impossible. For example, an individual may have had surgery or have a disability that impairs mobility. In another example, an individual may be in restricted mobility conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from individuals may be required for monitoring purposes or for clinical trials.

Toilet bowls and urinary catheters, such as Foley catheters, may be used to address some of these situations. However, toilet bowls and urinary catheters have several problems associated with them. For example, toilet bowls can cause discomfort, overflow, and other hygiene problems. Urinary catheters can be uncomfortable and painful and can lead to urinary tract infections.

Accordingly, users and manufacturers of fluid collection devices continue to seek new and improved devices, systems, and methods for collecting urine.

Embodiments disclosed herein relate to fluid collection devices and methods of using fluid collection devices. In one embodiment, a fluid collection device is disclosed. The fluid collector includes at least one wicking material including an outer surface. The fluid collection device includes a fluid impermeable coating adhered to at least a portion of the outer surface of the at least one wicking material, the fluid impermeable coating partially encapsulating the at least one wicking material within the fluid collection device. and defines an opening through which a portion of the at least one wicking material is exposed, the opening being positioned adjacent to the female urethra or through which the male urethra passes. configured to be placed.

In one embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid reservoir configured to hold fluid. A fluid collection system includes a fluid collection device that includes at least one wicking material that includes an outer surface. The fluid-collecting device includes a fluid-impermeable coating adhered to at least a portion of the outer surface of the at least one wicking material, the fluid-impermeable coating covering the chambers within the fluid-collecting device and the at least one wicking material. and an opening through which a portion is exposed, the opening being configured to be positioned adjacent to the female urethra or to have the male urethra positioned therethrough. The fluid collection system includes a conduit disposed within the chamber, the conduit including an inlet disposed within the chamber and an outlet configured to be fluidly coupled to the vacuum source. The fluid collection system includes a vacuum source fluidly coupled to one or more of the fluid reservoir or the outlet of the fluid collection device, the vacuum source configured to draw fluid from the fluid collection device.

In one embodiment, a method of collecting fluid is disclosed. The method includes placing an opening of a fluid collection device adjacent to or about a user's female urethra, the opening defined by a fluid impermeable coating of the fluid collection device. be. The method includes receiving fluid from the female urethra or the male urethra into a chamber of a fluid collection device, the chamber of the fluid collection device at least partially defined by a fluid impermeable coating.

Features from any of the disclosed embodiments may be used in combination with each other without limitation. Additionally, other features and advantages of the present disclosure will become apparent to those skilled in the art from a consideration of the following detailed description and accompanying drawings.
The drawings illustrate several embodiments of the present disclosure and like reference numerals refer to the same or similar elements or features in different views or embodiments shown in the drawings.

1 is an isometric view of a fluid collection device, according to one embodiment; FIG. 1B is a cross-sectional view of the fluid collection device along plane AA of FIG. 1A, according to one embodiment; FIG. 1B is a cross-sectional view of region B of FIG. 1B, in accordance with various embodiments; FIG. 1B is a cross-sectional view of region B of FIG. 1B, in accordance with various embodiments; FIG. 1 is an isometric view of a fluid collection device, according to one embodiment; FIG. 2B is a cross-sectional view along plane CC of the fluid collector of FIG. 2A, according to various embodiments; FIG. 2B is a cross-sectional view along plane CC of the fluid collector of FIG. 2A, according to various embodiments; FIG. 1 is an isometric view of a fluid collection device, according to one embodiment; FIG. 3B is a cross-sectional view along plane DD of the fluid collector of FIG. 3A, according to one embodiment. FIG. 1 is a block diagram of a system for fluid collection, according to one embodiment; FIG. 1 is a flow diagram of a method of collecting fluid, according to one embodiment. 1 is a flow diagram of a method of making a fluid collection device, according to one embodiment.

Embodiments disclosed herein relate to fluid collection devices and methods of use thereof. The devices and systems disclosed herein are configured to collect fluid from an individual. Fluids collected by the fluid collection device may include at least one of urine, vaginal secretions, penile secretions, reproductive fluids, blood, sweat, or other bodily fluids.

The fluid collection device includes a wicking material having a fluid impermeable coating that at least partially defines a chamber. The fluid impermeable coating also defines an opening extending therethrough, the opening being positioned adjacent to the female urethra or such that the male urethra is positioned therethrough. configured to The fluid collection device also includes a conduit having a channel extending between its inlet and outlet. The inlet is fluidly coupled to the chamber and the outlet is configured to be fluidly coupled to a fluid reservoir or vacuum source. The fluid impermeable coatings disclosed herein and fluid collection devices utilizing such coatings are soft, comfortable, and comfortable to the wearer, even in sensitive areas of the anatomy and under moist conditions. Provides a smooth feel.

Some conventional fluid collection devices may have a fluid impermeable shell that defines the outer surface of the device. The fluid-impermeable shell comprises a material that has a thickness that can create discontinuities in the surface of the device, or a material that has a relatively higher material hardness or texture than the absorbent material encapsulated therein. often. In some cases, conventional fluid-impermeable shells have differences in shape, thickness, and/or material composition (e.g., transition from hard to soft materials). These features may cause discomfort to the wearer's skin during use, especially during prolonged use (eg, an hour or more). For example, the transition from the fluid-impermeable shell material to the absorbent material therein may present a rim or other discontinuity that causes discomfort or even pain to the wearer's skin over time. Let Similarly, a relatively stiff material within the shell may not conform to the pressure exerted by the wearer's skin. Such stiffer materials can also cause discomfort or pain during long-term use.

The fluid collection devices disclosed herein have a fluid impermeable coating that provides the wearer of the fluid collection device with a smooth, comfortable feel even after extended use. sufficient thickness, compliance, material composition, and lack of surface features. For example, the fluid impermeable coating is sufficiently thin so as not to present a stiff or hard surface against the wearer's skin. The fluid-impermeable coating is sufficiently thin to conform to the pressure asserted thereon and provide a surface with little or no sharp edges or discontinuities. For example, the relatively thin fluid-impermeable coatings disclosed herein do not create a discontinuity when transitioning from the fluid-impermeable coating to the wicking material of the aperture. Accordingly, the fluid collection devices herein limit or eliminate pain and discomfort compared to conventional fluid collection devices.

FIG. 1A is an isometric view of a fluid collection device 100, according to one embodiment. FIG. 1B is a cross-sectional view along plane AA of the fluid collection device of FIG. 1A, according to one embodiment. Both FIGS. 1A and 1B are referenced below. Fluid collection device 100 may include fluid impermeable coating 102 and wicking material 115 . A wicking material 115 may be disposed within the fluid impermeable coating 102 . Fluid collection device 100 may also include conduit 108 . Conduit 108 may be at least partially disposed within wicking material 115 .

Fluid impermeable coating 102 at least partially defines at least a portion of the outer surface of fluid collection device 100 . Fluid-impermeable coating 102 at least partially defines chamber 104 of fluid collection device 100 (eg, the interior region of fluid collection device 100 ) and opening 106 . An opening 106 is defined by or formed in the fluid-impermeable coating 102 and extends therethrough to allow fluid to enter the chamber 104 from outside the fluid-collecting device 100 . allow to enter. Chamber 104 includes wicking material 115 and at least a portion of conduit 108 . Wicking material 115 is exposed through opening 106 . The opening 106 may be positioned in a portion of the fluid collection device 100 and is envisioned to be positioned adjacent the female urethra, eg, on or between the female user's labia majora. For example, the openings 106 may allow urine to pass from the wearer to the wicking material 115 to retain fluid within the chamber 104 at least temporarily.

Fluid impermeable coating 102 at least temporarily retains or stores fluid within chamber 104 . Fluid impermeable coating 102 may be formed of a material and/or have a thickness selected to provide a relatively soft feel of fluid collection device 100 against the wearer's skin. . Fluid impermeable coating 102 may be a thin layer of material disposed on or within outer surface 113 of wicking material 115 .

In some embodiments, the fluid impermeable coating 102 may be formed from a material with a relatively soft feel, such as a material having a hardness lower than average silicone. The fluid impermeable coating 102 disclosed herein prevents or limits discontinuities between the outer impermeable barrier or shell and the wicking material, for example when a conventional silicone outer shell is used. do. The relatively thin and/or soft material of the fluid-impermeable coating 102 prevents discomfort due to the relatively rigid or hard materials traditionally used in fluid collection devices when placed against the wearer and reduces the discomfort of the device. It provides a substantially uniform feel throughout and provides a relatively soft feel to the outer surface of the device compared to devices with molded fluid impermeable barriers.

Fluid-impermeable coating 102 may be formed from any suitable fluid-impermeable material, such as fluid-impermeable polymers, waxes, nanocelluloses, nanoparticles, other suitable materials, or combinations thereof. . Accordingly, fluid-impermeable coating 102 may prevent at least some of the fluid(s) from exiting portions of chamber 104 spaced from opening 106 . Fluid impermeable coating 102 may be a hydrophobic material. For example, fluid-impermeable coatings include silicone, polypropylene, polyethylene, polyethylene terephthalate, polystyrene, polyurethane, polycarbonate, polychloroprene, vinyl, polyvinyl chloride, latex, silanes (e.g., halogenated alkylsilanes), perfluorinated polymers, and the like. may include one or more of The fluid impermeable coating 102 may comprise superhydrophobic materials such as fluorocarbon polymers, fluorosilane polymers, metal oxide polystyrene nanocomposites (eg, MnO ₂ or ZnO), textured silica, carbon nanotubes, and the like. Fluid impermeable coating 102 may be an elastomeric material such as silicone rubber. Other suitable materials include thermoplastic elastomers, such as one or more of thermoplastic styrene-containing block copolymers, thermoplastic polyurethanes, thermoplastic copolyesters, thermoplastic olefins, thermoplastic polyamides, and the like.

In some examples, the fluid impermeable coating 102 can be oleophobic. In some examples, the material of fluid-impermeable coating 102 may also be configured to reduce or prevent dissolution of fluid-impermeable coating 102 in the presence of acidic or basic bodily fluids.

In some embodiments, the fluid impermeable coating 102 can be air permeable and fluid impermeable. In such an example, the fluid impermeable coating 102 may be formed of a hydrophobic material defining a plurality of pores, the pores sized to allow gas to pass through but liquid to be retained. molded.

The thickness of the fluid-impermeable coating 102 is kept to a minimum to provide a fluid-impermeable barrier, to have a smooth, discontinuous feel, and to allow the fluid collection device to reach most of the wicking material 115. Allows to have the overall feel of the outer part. For example, the thickness of fluid impermeable coating 102 may be thin enough to provide tactile sensation of the outermost portion of wicking material 115 (eg, fluid permeable membrane 118). Fluid impermeable coating 102 has a thickness of less than about 2 mm, about 10 μm to about 2 mm, about 500 μm to about 1.5 mm, about 100 μm to about 1 mm, about 1 mm to about 2 mm, about 10 μm to about 200 μm, about 10 μm to It can be about 500 μm, about 200 μm to about 500 μm, greater than about 500 μm, less than about 1 mm, less than about 500 μm, or less than about 100 μm.

In some examples, fluid-impermeable coating 102 may include multiple layers of any of the aforementioned materials. For example, the fluid-impermeable coating 102 may comprise a thin layer (eg, less than 1 mm) of textured silica-coated latex on the chamber-facing side, eg, on the outside of the latex layer or on the inside of the latex layer.

In one example, at least one or more portions of the outer surface of fluid-impermeable coating 102 may be formed from a soft and/or lubricious material, thereby reducing discomfort, chafing, or pain on the user's skin. do. For example, any of the materials disclosed herein for the fluid impermeable coating 102 may comprise one or more portions having a relatively smooth texture, e.g. Surface roughness measured by Ra value, such as 0.1 μm to 30 μm, 0.5 μm to about 20 μm, 1 μm to 10 μm, 0.1 μm to 5 μm, less than 20 μm, less than 15 μm, less than 10 μm, less than 5 μm, or 2 μm. Ra values less than

In some examples, the fluid-impermeable coating 102 may be relatively soft, such as having a relatively low hardness (a Shore A hardness value of less than 40, such as less than about 30, less than about 20, or less than about 10; In some cases, it has a Shore OO hardness value of less than about 50 or less than about 40). By using a relatively soft material, such as any described herein, the fluid-impermeable coating 102 has a relatively hard material, such as an average hardness (eg, Shore A hardness value of 40 or greater). It may be more comfortable than fluid collection devices that use outer shells such as those made from rubber or silicone.

Fluid impermeable coating 102 may include markings thereon, such as one or more markings, to assist the user in aligning device 100 to the wearer. For example, a line on the fluid-impermeable coating 102 (eg, opposite the opening 106) may allow the medical practitioner to align the opening 106 over the wearer's urethra. The markings may include one or more alignment guides or directional indicators, such as stripes or hashes. Such markings may be arranged to align device 100 with one or more anatomical features, such as the pubic bone.

As shown in FIG. 1B, a fluid impermeable coating 102 may be disposed on the outermost portion of wicking material 115 . For example, fluid impermeable coating 102 can be a layer of material adhered to outer surface 113 of wicking material 115 .

A wicking material 115 may be disposed within the fluid impermeable coating 102 . Wicking material 115 may include a permeable material, which is designed to wick fluid or allow fluid to pass through it. The permeability property referred to herein may be wicking, capillary action, diffusion, or another similar property or process, herein referred to as "permeability" and/or "wicking". be called. Such "wicking" may not include absorption into the wicking material. Wicking material 115 may collect fluid moving through opening 106 . Wicking material 115 may include more than one material, eg, multiple materials. The multiple materials may include multiple layers concentrically disposed within one another. Concentrically arranged layers of wicking material may exhibit a gradient of wicking, eg, the innermost wicking material contains the highest or lowest wicking ability of the plurality of materials. In some examples, multiple layers of wicking material may be arranged in a non-concentric fashion, e.g., the innermost layer of wicking material is one or more outer layers of wicking material(s). The layers and/or the fluid impermeable coating are off-center. In such an example, the conduit 108 may be disposed in the fluid collection device 100, such as in a non-concentrically disposed innermost layer of wicking material.

In some examples, wicking material 115 may include one or more of fluid permeable support 120 or fluid permeable membrane 118 . For example, fluid collection device 100 may include fluid permeable membrane 118 disposed within chamber 104 . Fluid permeable membrane 118 may cover at least a portion (eg, all) of opening 106 . Fluid permeable membrane 118 may be configured to wick any fluid away from opening 106 , thereby preventing fluid from escaping chamber 104 . The fluid permeable membrane 118 can also wick fluid generally towards the interior of the chamber 104 and is described in more detail below. Fluid permeable membrane 118 may comprise any material capable of wicking fluid. For example, the fluid permeable membrane 118 may comprise a cloth, such as gauze (eg, silk, linen, polyester, rayon, cotton, gauze blends), or another smooth cloth, or another smooth cloth. . Fluid permeable membrane 118 may comprise spun plastic fibers. In some examples, fluid permeable membrane 118 may comprise an open cell foam such as polyester foam. Forming fluid permeable membrane 118 from gauze, soft cloth, and/or smooth cloth may reduce friction caused by fluid collection device 100 rubbing against the user's skin.

Fluid permeable support 120 is disposed within chamber 104 , eg, concentrically within fluid permeable membrane 118 . Fluid permeable support 120 may support fluid permeable membrane 118 due to the relatively malleable configuration of fluid permeable membrane material 118 . For example, fluid permeable membrane 118 may be formed from a collapsible, thin, lightweight, or otherwise easily deformable material, such as a gauze-type cloth configured to wick but not absorb fluids. Accordingly, fluid permeable membrane 118 may be held in shape and position or otherwise supported by fluid permeable support 120 . In some examples, the fluid permeable support 120 can be positioned such that the fluid permeable membrane 118 is positioned between the fluid permeable support and the fluid impermeable coating 102 . Accordingly, fluid permeable support 120 may support and maintain the position of fluid permeable membrane 118 . Fluid permeable support 120 may comprise a relatively stiffer or denser material than fluid permeable membrane 118 . Fluid-permeable support 120 can be made from any fluid-permeable material that is less deformable than fluid-permeable membrane 118 , such as any of the materials disclosed herein for fluid-impermeable membrane 118 , to a higher density. or may be formed in a rigid form. For example, fluid permeable support 120 can comprise a porous polymer (eg, nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or open cell foam. Fluid permeable support 120 may comprise spun plastic fibers. In some examples, fluid permeable support 120 may be formed from natural materials such as cotton, wool, silk, or combinations thereof. In some examples, the fluid permeable support 120 can be formed from cloth, felt, gauze, or combinations thereof. Fluid permeable support 120 may be elastically flexible to help provide resilience and flexibility to fluid collection device 100 . In some examples, fluid permeable support 120 may be omitted from fluid collection device 100 . For example, wicking material 115 may include only fluid permeable membrane 118 . In some examples, fluid permeable membrane 118 may be optional. For example, wicking material 115 may include only fluid permeable support 120 . Fluid permeable support 120 may be denser than fluid permeable membrane 118 or may be made from a material that is stiffer than fluid permeable membrane 118 .

The wicking material 115 (eg, at least the fluid permeable support) may provide structural support to maintain the general shape of the fluid collection device 100, which may be elastically flexible. For example, wicking material 115 can be substantially cylindrical, substantially planar, substantially prismatic, and the like. Similarly, materials applied thereover (eg, fluid impermeable coating 102) may exhibit the same shape.

Fluid impermeable coating 102 and wicking material 115 may be configured to position conduit 108 at least partially within chamber 104 . For example, at least one of fluid permeable membrane 118 and fluid permeable body 120 may be configured to form a space that accommodates conduit 108 . In another example, fluid impermeable coating 102 may define an opening sized to receive conduit 108 (eg, at least one tube). At least one conduit 108 may be disposed within chamber 104 via opening 124, for example, via an opening formed in first end region 132 of the fluid collector. Aperture 124 may be sized and shaped to form an at least substantially fluid-tight seal with conduit 108 , thereby substantially preventing fluid from escaping chamber 104 . In some examples (not shown), opening 124 may be positioned over second end region 134 . In such an example, conduit 108 may be located only in second end region 134 and inlet 110 is located in second end region 134 (eg, reservoir 122, FIG. 2B).

By locating the inlet 110 at a location in the fluid collection device that is intended to be located at or near the gravimetrically low point of the chamber 104 when the fluid collection device is in the in-use position, the conduit 108 , allowing the inlet 110 to receive more fluid than if it were placed elsewhere, reducing the potential for pooling (e.g. fluid pooling can cause microbial growth and odor). . For example, fluid within wicking material 115 may flow in any direction due to capillary forces. However, fluid may exhibit a preference for flowing in the direction of gravity, particularly if at least a portion of wicking material 115 is saturated with fluid.

As discussed in more detail below, conduit 108 is sized to be coupled to and extend at least partially between one or more of a fluid reservoir (not shown) and a vacuum source (not shown). shape is determined. For example, conduit 108 is configured to connect directly to a vacuum source. In such examples, conduit 108 may extend at least 1 foot, at least 2 feet, at least 3 feet, or at least 6 feet from fluid impermeable coating 102 . In another example, conduit 108 is configured to be indirectly connected to at least one of a fluid reservoir and a vacuum source. In some examples, the conduit 108 may be secured to the wearer's skin using a catheter securement device, such as a C.I. R. Bard, Inc. STATLOCK® Catheter Securement Device, available from U.S.A. Inc. and disclosed, but not limited to, U.S. Pat. Nos. 6,117,163; 6,123,398; , the disclosures of which are all incorporated herein by reference in their entirety.

The term "coating" is not intended to be limited only to materials disposed on the outer surface of another material, but rather coatings may be applied over the wicking materials disclosed in more detail herein. , or an entire layer disposed therein, a portion of a layer, or a separate layer.

As shown in FIGS. 1C and 1D, a fluid-impermeable coating 102 may be placed over or within the wicking material 115 . 1C and 1D are cross-sectional views of region B of FIG. 1B. As shown in FIG. 1C, fluid collection device 100c includes fluid impermeable coating 102 disposed on outer surface 113 of wicking material 115 (eg, fluid permeable membrane 118). Fluid collection device 100c is similar or identical to fluid collection device 100 in one or more aspects. Fluid impermeable coating 102 is deposited on surface 113 of wicking material 115 . Fluid impermeable coating 102 may be cast, coated, wrapped, sprayed, or otherwise deposited onto surface 113 to a selected thickness, such as any of the thicknesses disclosed herein. In some examples, the fluid-impermeable coating may be adhered, such as with an adhesive, to the outermost portion of the wicking material (e.g., the fluid-impermeable membrane), or the wicking material may be coated with, for example, a dip coating. may be interfacially self-bonded via

In some embodiments, fluid impermeable coating 102 may be at least partially embedded or otherwise disposed on the outermost portion of wicking material 115 . As shown in FIG. 1D, fluid collection device 100d includes fluid impermeable coating 102 embedded in outer surface 113 of wicking material 115 (eg, fluid permeable membrane 118). Fluid collection device 100d is similar or identical to fluid collection device 100 in one or more aspects. Fluid impermeable coating 102 is deposited on the outermost portion of wicking material 115 and at least partially defines surface 113 of wicking material 115 . In such instances, the outer surface of fluid impermeable coating 102 may be coextensive with outer surface 113 of wicking material 115, as shown. In some examples (not shown), the outer surface of fluid impermeable coating 102 may extend from within wicking material 115 and beyond outer surface 113 of wicking material 115 . The fluid impermeable coating 102 is cast, cast, or cast into the wicking material 115 at the surface 113 to a selected depth (e.g., coating thickness), e.g., any of the thicknesses disclosed herein. It may be coated, sprayed, impregnated, or otherwise incorporated. In application, the wicking material 115 may at least partially wick the fluid impermeable membrane material to its outer surface. In such instances, the fluid impermeable coating material may penetrate into the wicking material 115 sufficiently to render the penetrated portion of the wicking material fluid impermeable.

As shown in FIG. 1B, wicking material 115 (eg, one or more of fluid permeable membrane 118 or fluid permeable support 120) at least substantially occupies the portion of chamber 104 not occupied by conduit 108. can be fully satisfied. For example, wicking material 115 may cover portions of chamber 104 not occupied by conduit 108 if fluid impermeable coating 102 is disposed over the entire exterior surface of wicking material 115 (except opening 106). can satisfy

In some examples (FIGS. 2A-3B), fluid permeable membrane 118 and fluid permeable support may not substantially completely fill the portion of chamber 104 not occupied by conduit 108 . In such examples, fluid collection device 100 may include a reservoir (eg, void) disposed in chamber 104 . The reservoir can be a void defined between the wicking material in the chamber 104 and the inner surface of the fluid impermeable coating 102 or end cap (FIGS. 2A-3B). At least some of the fluid wicked by wicking material 115 may be drawn from wicking material 115 and collected in a reservoir.

Returning to FIGS. 1A and 1B, conduit 108 may be disposed within wicking material 115 and fluidly coupled (e.g., tubing or other material) to inlet 110 disposed within fluid collection device 100 and a vacuum source. and an outlet for connecting (fluidically connected in a manner of Conduit 108 may comprise a flexible material such as plastic tubing (eg, medical tubing). Such plastic tubing may include tubing of thermoplastic elastomers, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, and the like. In some examples, conduit 108 may comprise silicone or latex. Conduit 108 includes an inlet 110 at a second end region 134 and an outlet 112 at a first end region 132 located downstream from inlet 110 . Inlet 110 of conduit 108 fluidly couples chamber 104 to a fluid reservoir or to a vacuum source for removing fluid from fluid collection device 100 . Fluid may be removed from chamber 104 via conduit 108 . When a suction or vacuum force is applied or created to conduit 108 by a vacuum source (FIG. 4), fluid in chamber 104 is drawn into inlet 110 and out of fluid collector 100 through conduit 108 . can be

In some examples, the inlet 110 may be located in the innermost or gravimetrically low spot within the chamber 104 . For example, conduit 108 may extend far enough into chamber 104 to locate inlet 110 at a gravimetrically low point of chamber 104 , eg, a fluid reservoir within chamber 104 of fluid collection device 100 .

Fluid collection device 100 and its components may be deformable (eg, bendable) in response to pressure applied thereto. For example, the fluid collection device 100 and its components may flex to conform to the user's anatomical contours, for example, when positioned between a garment and the user. In an example, fluid collection device 100 may flex when placed proximate the urethra (e.g., between the labia) when fluid collection device 100 is positioned on a wearer (e.g., a user).

Fluid collection device 100 is an example of a female fluid collection device 100 and is sized, shaped, or otherwise configured to receive fluid from a female user. For example, fluid collection device 100, or at least one of the components therein, may be substantially cylindrical, elliptical, prismatic, or any other shape suitable for complementing or contouring the vaginal area of a female subject. can be in the form of Opening 106 may be configured to be placed adjacent to the female urethra. The opening 106 may be located on an upward or inward (eg, toward the user) facing portion of the fluid collection device 100 .

In the illustrated example, conduit 108 is disposed at least partially within chamber 104 . For example, conduit 108 may extend from first end region 125 into fluid impermeable coating 102 and to second end region 127 at a point proximate the end of fluid collection device 100 . (a portion of the device configured to be placed at a gravimetrically low point of the device during use). As shown in FIG. 1B, the end of inlet 110 may be offset from fluid impermeable coating 102 to allow fluid to be drawn therethrough. In some examples, conduit 108 may be perforated, such as at an inlet end, to allow radial collection of fluid from the wicking material. In some examples (not shown), conduit 108 enters second end region 127 and inlet 110 of conduit 108 may be located at second end region 127 . Fluid collected in fluid collection device 100 may be removed from the interior region of chamber 104 via conduit 108 . Conduit 108 may comprise a flexible material such as plastic tubing (eg, medical tubing) as disclosed herein. In some examples, conduit 108 may include one or more portions that are elastic, eg, by having one or more diameters or wall thicknesses that allow the conduit to be flexible.

Fluid collection device 100 may be placed proximate to the female urethra (e.g., over or between the labia) such that urine enters chamber 104 of fluid collection device 100 through opening 106. can be done. Fluid collection device 100 receives fluid into chamber 104 through opening 106 . For example, opening 106 may exhibit an elongated shape that extends from a first location below the urethral opening (eg, at or near the anus or vaginal opening) to a second location above the urethral opening. (eg, at or near the clitoris or mons pubis). The opening 106 may exhibit an elongated shape because the space between the woman's legs is relatively small when the woman's legs are closed, thereby providing a path corresponding to the elongated shape of the opening 106. Allows fluid flow only along. The openings 106 in the fluid-impermeable coating 102 can exhibit a width measured transversely to the length of the fluid collection device 100 and are at least about 10% of the circumference of the fluid collection device 100. for example, about 25%, 30%, 40%, 50%, 60%, 75%, 85%, 100% around the circumference of the fluid collection device 100, or a range between any combination of the foregoing. be. Aperture 106 can exhibit a width greater than 50% of the circumference of fluid collection device 100 because vacuum (eg, suction) draws fluid into conduit 108 .

In one example, one or more portions of fluid impermeable coating 102 may be configured to be attached to a patient or to clothing worn by a user, and may be attached, for example, with an adhesive (e.g., hydrogel adhesive, e.g., Using the hydrogel layer disclosed in US Pat. No. 10,226,376, the disclosure of which is incorporated herein in its entirety by this reference). In some examples, openings 106 may be longitudinally oriented (eg, having major axes parallel to the longitudinal axis of device 100). In some embodiments (not shown), openings 106 may be laterally oriented (eg, having major axes perpendicular to the longitudinal axis of device 100).

In one example, conduit 108 is configured to be insertable into at least chamber 104 . In one such example, conduit 108 may include one or more markers (not shown) on its exterior that are configured to facilitate insertion of conduit 108 into chamber 104 . For example, the conduit 108 may include one or more markings thereon that are configured to prevent over- or under-insertion of the conduit 108, e.g. or defining an inlet 110 configured to be positioned adjacent to the reservoir (FIGS. 2B and 2C). In another example, conduit 108 may include one or more markings thereon configured to facilitate accurate rotation or depth of insertion of conduit 108 into chamber 104 . In one example, the one or more markings may include lines, dots, stickers, or any other suitable markings. In some examples, the conduit may be matte or opaque (eg, black) to obscure the visibility of fluid therein.

Further examples of fluid impermeable materials, fluid permeable membranes, fluid permeable supports, chambers and their shapes and configurations are described in U.S. patent application Ser. and in U.S. Patent Application No. 15/260,103, filed September 8, 2016 (published December 29, 2016 as U.S. Patent Application Publication No. 2016-0374848). , the disclosures of each of which are incorporated herein by reference in their entireties.

In some examples, fluid collection device 100 may include a reservoir therein. In such examples, the fluid collection device may include one or more end caps that retain the first end region and the second end region of wicking material therein. configured as

FIG. 2A is an isometric view of a fluid collection device 200, according to one embodiment. FIG. 2B is a cross-sectional view along plane CC of the fluid collection device of FIG. 2A, according to one embodiment. 2A and 2B are described in detail below. Fluid collection device 200 may be similar or identical to fluid collection device 100 in one or more aspects. For example, fluid collection device 200 includes fluid impermeable coating 102, wicking material 115, and conduit 108 as disclosed herein. Fluid collection device 200 includes at least one end cap, eg, first end cap 232 and second end cap 234 . A wicking material 115 may be disposed within the fluid impermeable coating 102 . At least one end cap may be positioned over the fluid impermeable coating 102 and the wicking material 115 at the first end region 125 and the second end region 127 . Collectively, fluid impermeable coating 102 and at least one end cap define chamber 104 . Fluid collection device 200 may include reservoir 122 within chamber 104 , for example, a void defined between second end cap 234 and wicking material 115 . Fluid collection device 200 may also include conduit 108 . Conduit 108 may be at least partially disposed within wicking material 115 as disclosed herein.

As shown, the fluid impermeable coating 102 may be disposed over the wicking material 115 and the end caps 232 and 234 are disposed over the end regions of the coated wicking material. good too. The end caps may be sealed to the fluid impermeable coating via a tension fit, fluid impermeable adhesive, or the like. The first and second end caps 232 and 234 can have selected cross-sectional shapes (eg, when viewed along the longitudinal axis), such as circular, oval, triangular, rectangular, and the like. End caps 232 and 234 may hold wicking material 115 in a selected cross-sectional shape. For example, first and second end caps 232 and 234 can hold wicking material 115 in a substantially cylindrical configuration, as shown.

A first end cap 232 may be placed over the wicking material 115 and the fluid impermeable coating 102 at the first end region 125 of the fluid collection device 200 . First end cap 232 may include opening 124 sized and shaped to receive and seal conduit 108 therethrough.

A second end cap 234 may be positioned over the wicking material 115 and the fluid impermeable coating 102 at the second end region 127 . The second end cap 234 at least partially defines the reservoir 122 and collects fluid therein. Fluid impermeable coating 102 may also at least partially define reservoir 122 .

At least one end cap may be formed of a fluid impermeable material. For example, end caps 232 and 234 may be made of the same or similar material as fluid impermeable coating 102 . At least one end cap (e.g., second end cap 234) may comprise a material that is stiffer than fluid impermeable coating 102, e.g., to allow reservoir 122 to retain a substantially constant volume during use. allow to maintain. At least one end cap may be made of a resilient material to retain and return to a selected shape when deformed by external pressure.

Reservoir 122 may be located in the portion of chamber 104 (eg, second end region) closest to inlet 110 , such as under second end cap 234 . However, reservoir 122 may be positioned at different locations within chamber 104 . For example, reservoir 122 may be positioned at the end of chamber 104 closest to outlet 112 , such as under first end cap 232 . In another example, fluid collection device 100 can include multiple reservoirs, for example, a first reservoir located at second end region 127 and a second reservoir located at first end region 125 . is. In another example, fluid permeable support 120 is spaced from at least a portion of conduit 108 and reservoir 122 can be the space between fluid permeable support 120 and conduit 108 .

As shown in FIG. 2B, inlet 110 of conduit 108 may be coextensive with an end of wicking material 115 at the second end region of fluid collection device 200 . In some examples, inlet 110 of conduit 108 may extend beyond the end of wicking material 115 at the second end region of fluid collection device 200 . In some examples, inlet 110 of conduit 108 may be disposed within wicking material 115 , for example, nested inside a channel of wicking material 115 at the second end region of fluid collection device 200 . be

In some examples, one or more of the wicking material 115 and the fluid impermeable coating 102 in the first and/or second end regions of the fluid collection device 200 have substantially constant dimensions (e.g., diameter ) on the outer surface of the fluid collection device. Such a stepped configuration may include a tapering diameter at the second end region 127 of the wicking material 115 to increase the thickness of the fluid impermeable coating 102 and/or the second end cap 234. corresponds to Accordingly, the fluid collection device 200 can have a substantially smooth outer surface without cusps, gaps, or other discontinuities.

In some embodiments, a fluid impermeable coating 102 can be disposed over the wicking material 115 and at least one end cap.

2C is a side cross-sectional view along plane CC of the fluid collection device of FIG. 2A, according to one embodiment. FIG. 2C shows a fluid collection device 200c. Fluid collection device 200c may be similar or identical to fluid collection device 100 or 200 in one or more aspects. For example, fluid collection device 200 c includes wicking material 115 , at least one end cap, wicking material 115 , and one or more of conduits 108 disposed within fluid impermeable coating 102 . As shown, fluid impermeable coating 102 may be disposed over wicking material 115 and end caps 232 and 234 generally via spray application, dip coating, direct application, or the like. End caps 232 and 234 may be sealed with a fluid impermeable coating along with wicking material 115 . The end caps and/or the fluid impermeable coating 102 thereon may help retain the shape of the wicking material 115 . In some examples, fluid impermeable coating 102 is applied over a portion of wicking material 115 (eg, to form opening 106), first end cap 232, and second end cap 234. can be placed in For example, opening 106 may be formed by masking a portion of wicking material 115 with a masking agent and dip coating the wicking material and first and second end caps 232 and 234 with a fluid impermeable coating material. can be formed. Masking agent may be removed from the wicking material to reveal openings 106 .

A first end cap 232 may be positioned within the fluid impermeable coating 102 of the first end region 125 of the fluid collection device 200c over the wicking material 115 . At least one end cap may be formed of a fluid impermeable material, as disclosed above. First end cap 232 may include opening 124 sized and shaped to receive and seal conduit 108 .

A second end cap 234 may be positioned within the fluid impermeable coating 102 of the second end region 127 over the wicking material 115 . Second end cap 234 at least partially defines reservoir 122 to collect fluid therein. In such examples, reservoir 122 may be a void defined between second end cap 234 and wicking material 115 .

As shown in FIG. 2C, in some embodiments, inlet 110 of conduit 108 may extend beyond the end of wicking material 115 at the second end region of fluid collection device 200c. In some embodiments, the inlet 110 of the conduit 108 may be coextensive with the end of the wicking material 115 or inside the channel of the wicking material 115 at the second end region 127 . may be included.

In some examples, the wicking material 115 may have a stepped configuration selected to correspond to the thickness of one or more of the at least one end cap and the fluid impermeable coating 102. to provide the fluid collection device with a substantially smooth outer surface when the fluid impermeable coating is applied thereon. Such a stepped configuration may include tapering diameters at one or more of the first and second end regions 125 and 127 of the wicking material 115 and the first and second end caps 232 . and 234. Accordingly, the fluid collection device 200 can have a substantially smooth outer surface without cusps, gaps, steps, or other discontinuities. By coating the wicking material 115 and at least one end cap with the fluid impermeable coating 102, the fluid collection device 200c may be less prone to leakage than the fluid collection device 200, which includes transitions between materials on the outer surface. have a nature.

Fluid collection devices for use by women are disclosed with respect to FIGS. 1A-2C, although in some embodiments fluid collection devices sized and shaped for use by men are also disclosed. .

FIG. 3A is an isometric view of a fluid collection device 300, according to one embodiment. FIG. 3B is a cross-sectional view of the fluid collection device 300 of FIG. 3A, according to at least some embodiments. 3A and 3B, fluid collection device 300 includes receptacle 350 and sheath 352 (eg, a cup-shaped container). The receptacle 350 is placed over the skin surrounding the male urethra and is sized, shaped, and made of a material to be placed through the male urethra. For example, receptacle 350 may include an annular base 354 that defines an opening 356 of receptacle 350 . The annular base 354 is sized and shaped to be placed around the male urethra (eg, placed around the penis) and the opening 356 is positioned through the male urethra. can be configured as follows. The annular base 354 is also sized to be attached (eg, adhesively attached, eg, using a hydrogel adhesive, etc.) or placed on clothing about the male urethra (eg, about the penis). , molded, made of material, or otherwise constructed. Receptacle 350 may be formed of any material disclosed herein for fluid impermeable coating 102, such as a silicone polymer. In one example, the annular base 354 may represent the general shape of the skin surface to which the annular base 354 is selected and/or thereby allow the annular base 354 to conform to any shape of the skin surface. It may be flexible to allow for Receptacle 350 also defines a hollow region configured to receive (eg, seal) sheath 352 . For example, receptacle 350 may include flange 360 extending longitudinally from annular base 354 . Flange 360 has a height sufficient to prevent accidental removal of sheath 352 from receptacle 350 (eg, at least 0.5 cm high, 1 cm high, at least 2 cm high, or at least 5 cm high). ). Flange 360 is shown disposed within sheath 352, but may be disposed on the outer surface of sheath 352 in some examples.

Sheath 352 includes (eg, may be formed from) fluid-impermeable coating 302 that fits within or around opening 356 (eg, hollow region) and/or flange 360 of receptacle 350 . The size is determined and molded. A fluid impermeable coating 302 may be disposed over the wicking material 315 . The sheath 352 can be shaped to contain and accommodate different sizes and conditions of the male penis. For example, sheath 352 may be generally cup-shaped or tubular, with a substantially closed end. In some examples, sheath 352 can be substantially cylindrical with a closed distal end. Cylindrical sheath 352 may be "substantially" cylindrical, which means that the cylindrical shape is deformable based on the size and condition of the wearer's penis and is at least partially collapsible/expandable. in terms of getting Accordingly, the wearer's penis may be inserted into and contained within sheath 352, whether in a relaxed or upright position.

Fluid-impermeable coating 302 may be similar or identical to fluid-impermeable coating 102 in one or more aspects. Fluid impermeable coating 302 at least partially defines chamber 304 therein. The fluid-impermeable coating 302 may also define an opening 306 extending through the fluid-impermeable coating 302 that is configured to place the male urethra therethrough. Fluid impermeable coating 302 may also include at least one opening 362 that allows chamber 304 to remain substantially at atmospheric pressure. Aperture 362 may be located in any portion of sheath 352, eg, a portion not intended to act as a reservoir for collected fluid. In some examples (not shown), opening 362 may extend through cap 366 or may be located below cap 366 . In some instances, fluid collection device 300 may not include opening 362 , eg, where a more complete seal is desired for chamber 304 .

A fluid-impermeable coating 302 is disposed on, or at least partially permeated by, the outer surface of wicking material 315 to provide a fluid-impermeable coating that separates the interior of fluid collection device 300 (eg, chamber 304) from the external environment. It can form a permeable barrier. Wicking material 315 may be similar or identical in one or more aspects to wicking material 115 disclosed herein. For example, wicking material 315 includes one or more of fluid permeable membrane 118 or fluid permeable support 120 disclosed herein. In some examples, fluid permeable membrane 118 or fluid permeable support 120 may be omitted from wicking material 315 . Fluid impermeable coating 302 may be adhered to the outer surface of wicking material 315 (eg, fluid permeable membrane 118 or fluid permeable support 120). Stated another way, the fluid permeable support 120 can be disposed on the inner surface of the fluid impermeable coating 302 . The fluid permeable membrane 118 may be disposed on the inner surface of the fluid permeable support 120 , eg, arranged concentrically within the fluid permeable support 120 . In such instances, the fluid permeable membrane 118 may contact the wearer's (eg, penis) skin during use. In some examples (not shown), fluid permeable membrane 118 can be disposed on the outer surface of wicking material 315, where fluid impermeable coating 302 is adhered to the outer surface of fluid permeable membrane 118. be. One or more of fluid permeable membrane 118 or fluid permeable support 120 may extend around at least a portion of the inner surface of fluid impermeable coating 302 .

To facilitate fluid collection and provide comfort, the sheath 352 may be flexible, relatively soft, and have a relatively smooth outer surface so that the sheath 352 conforms to the shape of the penis. make it possible to respond to For example, the sheath 352 can be at least partially collapsed when the penis is relaxed and at least partially expanded and bent to the shape of the penis as the penis stands upright.

Receptacle 350 may be stiffer than sheath 352 . For example, receptacle 350 can be formed from a flexible polymer that is at least one thicker than the entire sheath 352 or that exhibits a greater Young's modulus than sheath 352 . Accordingly, receptacle 350 can provide some structural support at or near proximal end 342 of fluid collection device 300 . The higher stiffness of receptacle 350 may keep receptacle 350 open thereby facilitating insertion of the urethra (eg, penis) into fluid collection device 300 . The relative rigidity of receptacle 350 allows receptacle 350 to serve as an attachment point to the wearer, wicking material 315 and/or fluid impermeable coating 302 . In some examples, the receptacle 350 may define a recess, include threads, or include another optional mounting substrate for attaching a component of the fluid collection device 300, such as a wicking material 315 or coating 302. .

In some examples, fluid collection device 300 includes cap 366 at distal end region 344 . Cap 366 defines an internal channel through which fluid may be removed from fluid collection device 300 . The internal channel is in fluid communication with chamber 304 . Cap 366 may be disposed over at least a portion of one or more distal end regions 344 of fluid impermeable coating 302 or wicking material 315 . Cap 366 may be made of polymer, rubber, or other fluid impermeable material. Cap 366 may be attached to one or more of fluid impermeable coating 302 , wicking material 315 , or conduit 108 . Cap 366 may have a laterally extending flange 370 and a longitudinally extending flange 372 . A laterally extending flange 370 may cover at least a portion of the distal end region 344 of the fluid collection device 300 . A longitudinally extending flange 372 may extend a distance from the wicking material 315 . Longitudinally extending flange 372 is sized and configured to receive and fluidly seal conduit 108, such as within an interior channel. The conduit 108 may extend a distance within the cap 366 , for example to, through the wicking material 315 , or to a point away from the wicking material 315 . In the latter example, as shown in FIG. 3B, the internal channel of cap 366 may define reservoir 322 therein. Reservoir 322 is the unoccupied portion of cap 366 and is devoid of other material. In some examples, reservoir 322 is at least partially defined by wicking material 315 and cap 366 . During use, fluid within chamber 304 may flow through wicking material 315 to reservoir 322 . Reservoir 322 may store at least some of the fluid therein and/or position the fluid for removal by conduit 108 . In some examples, at least a portion of the wicking material 315 may extend continuously between at least a portion of the inner channel opening and the chamber 304 to wick fluid directly from the opening to the reservoir 322 .

In some examples (not shown), fluid impermeable coating 302 may be disposed over cap 366 , enclosing cap 366 within chamber 304 , for example.

In some examples, sheath 352 can include at least a portion of conduit 108 therein, eg, at least partially disposed within chamber 304 . For example, conduit 108 may extend from sheath 352 to an area at least proximate opening 356 . The area proximate opening 356 may be placed near or on the skin around the male urethra (eg, on the penis). Therefore, when the patient is lying on their back, fluid (eg, urine) can collect near the opening 306 against the wearer's skin. Fluid may be removed from chamber 304 via conduit 108 . Conduit 108 may be disposed within the wicking material and includes an inlet disposed within the fluid collector and an outlet configured to be fluidly coupled to a vacuum source.

Receptacle 350, sheath 352, cap 366, and conduit 108 may be attached together using any suitable method. For example, at least two of receptacle 350, sheath 352, cap 366, or conduit 108 may be an interference fit, adhesive, stitching, welding (e.g., ultrasonic welding), tape, other suitable method, or the like. can be attached together using at least one of the combinations of

In some examples, a vacuum source (not shown) may be positioned remotely from sheath 352 . In such instances, conduit 108 may extend out and away from sheath 352 to a vacuum source or fluid reservoir. For example, the inlet of the conduit can be used to remove fluid from the chamber 304 via a vacuum, while the outlet (not shown) of the conduit 108 is or is operably coupled to a vacuum source. Fluidly coupled to the fluid reservoir.

In some examples (not shown), fluid collection device 300 does not include cap 366 . In such examples, the fluid-impermeable coating 302 may include at least one opening sized and shaped to receive and seal the conduit 108 within, for example, the chamber 304 . In such instances, the outlet of conduit 108 may be fluidly coupled to a fluid reservoir or vacuum device (not shown). Accordingly, the interior region of chamber 304 may be fluidly coupled to a vacuum source via conduit 108 . Fluid in chamber 304 may be removed through conduit 108 when the vacuum source applies vacuum/suction. In some examples, the fluid may be pumped via a vacuum source (not shown) to a section of conduit 108 fluidly coupled to a fluid reservoir (not shown) where the fluid may be deposited.

In an example, a portion of chamber 304 may be substantially empty due to the varying size and stiffness of the male penis. However, in some examples (not shown), the outermost region of chamber 304 (eg, around the interior region of sheath 352) may include wicking material 115 at a location to prevent wicking from the male urethra. and/or direct fluid to selected areas of the chamber 304. Because chamber 304 is substantially empty (eg, substantially all of chamber 304 forms a reservoir), fluid tends to pool at gravimetrically low points in chamber 304 . Depending on the orientation of the wearer, the gravimetrically low point of chamber 304 is the intersection of the device with the wearer's skin (proximate opening 356), the corner formed in sheath 352, and the distal portion of chamber 304. It can be at the end region 344, or other suitable location. The inlet of the conduit 108 may be positioned at or near the gravimetrically low point of the chamber 304 depending on the orientation of the user, eg, whether the user is supine, sideways, or standing.

During operation, a man using fluid collection device 300 may expel fluid (eg, urine) into chamber 304 . Fluid may pool in chamber 304 or otherwise collect, for example, against the skin of a user (such as a wearer). At least some of the fluid is allowed to enter the interior of conduit 108 via the conduit inlet. Fluid may be drawn out of the fluid collection device 300 via vacuum/suction supplied by a vacuum source. In some examples, during operation, opening 362 substantially reduces the pressure in chamber 304 to atmospheric pressure even if fluid is introduced into chamber 304 and subsequently removed from chamber 304 . can be maintained at

When a vacuum source ( FIG. 4 ) applies vacuum/suction to conduit 108 , fluid(s) within chamber 104 or 304 (eg, second end region 244 , such as within reservoir 322 ) is forced through conduit 108 . can be drawn into and withdrawn from the fluid collection device 100, 200, or 300 by means of the fluid collector 100, 200, or 300.

FIG. 4 is a block diagram of a system 400 for fluid collection, according to one embodiment. System 400 includes fluid collection device 401 , fluid reservoir 419 , and vacuum source 429 . Fluid collection device 401 , fluid reservoir 419 , and vacuum source 429 may be fluidly coupled to each other via one or more conduits 108 . For example, fluid collection device 401 may be operably coupled to one or more of fluid reservoir 419 or (portable) vacuum source 429 via conduit 108 . Fluid collection device 401 can be similar or identical to any of the fluid collection devices disclosed herein, such as male or female fluid collection devices.

Fluid (eg, urine or another bodily fluid) collected in fluid collection device 401 may be removed from fluid collection device 401 via conduit 108 , which is an interior region (eg, chamber) of fluid collection device 401 . protrude to For example, a first open end of conduit 108 may extend to a reservoir within fluid collection device 401 . A second open end of conduit 108 may extend into fluid collection device 401 or vacuum source 429 . A suction force may be introduced into the interior region of fluid collection device 401 via the first open end of conduit 108 in response to a suction force (eg, vacuum) applied to the second end of conduit 108 . . Suction may be applied directly or indirectly to the second open end of conduit 108 by vacuum source 429 .

Suction may be applied indirectly through fluid reservoir 419 . For example, a second open end of conduit 108 may be fluidly coupled to or disposed within fluid reservoir 419 and an additional conduit 108 may extend from fluid reservoir 419 to vacuum source 429. . Thus, vacuum source 429 can apply suction to fluid collection device 401 through fluid reservoir 419 . As fluid is expelled from the chamber, it may travel through the first section of the conduit to the fluid reservoir where it may be retained. Fluids such as urine may thus be evacuated from the fluid collection device 401 using the vacuum source 429 . In some examples, suction may be applied directly through vacuum source 429 . For example, the second open end of conduit 108 may be positioned within vacuum source 429 . Additional conduits 108 may extend from vacuum source 429 to a point outside fluid collection device 401 , eg, to fluid reservoir 419 . In such instances, vacuum source 429 may be positioned between fluid collection device 401 and fluid reservoir 419 .

In some examples, the fluid storage container 419 is a bag (eg, a drainage bag), a bottle or cup (eg, a collection jar), or any other enclosed container for storing bodily fluids such as urine. can include

The vacuum source 429 can be a manual vacuum pump and one of an electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to generate a vacuum. may include one or more. Vacuum source 429 may provide vacuum or suction to remove fluid from fluid collection device 401 . In examples, the vacuum source 429 is powered by one or more of a power cord (eg, connected to a power socket), one or more batteries, or even a manual power source (eg, a manual vacuum pump). can be The vacuum source 429 disclosed herein may include one or more of switches, buttons, plugs, remote controls, or any other device suitable for activating the vacuum source 429 .

FIG. 5 is a flow diagram of a method 500 of collecting fluid, according to one embodiment. The method 500 may include an act 510 of "positioning an opening of a fluid collection device adjacent to or around a user's female urethra, wherein the opening: defined by the fluid impermeable coating of the fluid collection device." Operation 510 may be followed by operation 520, wherein operation 520 is "receiving fluid from the female urethra or the male urethra into a chamber of the fluid collection device, the chamber of the fluid collection device being fluid impermeable. defined at least in part by a protective coating."

Operations 510 and 520 of method 500 are for illustrative purposes. For example, operations 510 and 520 of method 500 may be performed in different orders, split into multiple operations, modified, supplemented, or combined. In one example, one or more of operations 510 and 520 may be omitted from method 500 . For example, method 500 may not include operation 510 . Either operation 510 or 520 may involve using any of the fluid collection devices, vacuum sources, fluid reservoirs, systems, or components thereof disclosed herein. For example, the fluid collection device can include a fluid-impermeable coating that at least partially defines a chamber, the fluid-impermeable coating also defining an opening extending therethrough, the opening communicating with the female urethra. Adjacently positioned or configured for placement therethrough of the male urethra. The fluid collection device may include a wicking material disposed with the chamber and a conduit disposed within the wicking material, the conduit including an inlet and an outlet disposed within the fluid collection device.

Act 510 is "positioning the opening of the fluid collection device adjacent to or about the user's female urethra, the opening being defined by a fluid impermeable coating of the fluid collection device. be done.” The fluid collection device can be a female fluid collection device, such as any of those disclosed herein. The fluid collection device can be a male fluid collection device, such as any of those disclosed herein. Positioning the opening of the fluid collection device adjacent the user's female urethra may include positioning the opening against, between, or inside the labia majora of the female user. . Positioning the opening of the fluid collection device adjacent the user's female urethra may include positioning the second end region of the fluid collection device in the female user's gluteal cleft. Placing the opening of the fluid collection device adjacent to the user's female urethra or around the male urethra can be used to place the fluid collection device in place on the user, tape, glue, wrap, or attach to clothing. It can include securing via insertion or the like. Positioning the opening of the fluid collection device about the male urethra of the user may include positioning the opening of the male fluid collection device about the penis of the user (eg, the wearer). In such an example, the method 500 may include placing a male fluid collection device sheath in the hollow region of the receptacle so that the male urethra is positioned through an opening in the male fluid collection device sheath. be done.

Operation 520 is "receiving fluid from the female urethra or the male urethra into a chamber of the fluid collection device, the chamber of the fluid collection device being at least partially defined by a fluid impermeable coating." describe. For example, operation 520 may include wicking fluid away from the urethra through an opening or chamber using, for example, wicking materials (eg, fluid permeable membranes and fluid permeable supports). Action 520 may include drawing fluid away from the urethra, eg, into a reservoir within a fluid collection device. Operation 520 may include flowing fluid toward a portion of the chamber that is fluidly coupled to an inlet of a conduit (eg, a conduit in fluid communication with a vacuum source) for removing fluid from the chamber. For example, operation 520 may include flowing fluid to a substantially unoccupied portion (eg, reservoir) of the chamber, a gravimetrically low point of the chamber.

The method 500 may include applying suction with a vacuum source effective to draw fluid from the chamber via a conduit disposed within the chamber and fluidly coupled to the vacuum source. In an example, applying suction by a vacuum source effective to draw fluid from the chamber via a conduit disposed within the chamber and fluidly coupled to the vacuum source is disclosed herein. using any of the vacuum sources provided. In one example, applying suction may include activating a vacuum source (eg, a suction device) in fluid communication with an inlet of a conduit in the fluid collection device. In examples, activating a vacuum source in fluid communication with the inlet of a conduit in the fluid collection device includes flipping an on/off switch, pressing a button, plugging the vacuum source into a power outlet, applying vacuum Powering the vacuum source may be included, such as by one or more of placing a battery into the source. In examples, the vacuum source can include a manual vacuum pump, and applying suction with the vacuum source includes manually operating the manual vacuum pump effective to draw fluid from the chamber. obtain.

In an example, applying suction by a vacuum source effective to draw fluid from the chamber can be effective to remove at least some fluid (eg, urine) from the chamber of the fluid collector. In an example, applying suction by a vacuum source effective to draw fluid from the chamber via a conduit disposed within the chamber and fluidly coupled to the vacuum source may be applied to the chamber of the fluid collection device. can be effective in transferring at least some of the fluid from the container to a fluid storage container (eg, bottle or bag) fluidically coupled thereto. In examples, the vacuum source may be remote from the fluid collector.

In an example, applying suction by a vacuum source effective to draw fluid from the chamber via a conduit disposed within the chamber and fluidly coupled to the vacuum source may reduce the humidity in the chamber. (eg, via one or more humidity sensors) and, in response, activating a vacuum source to provide suction into the chamber. Control of the vacuum source in response to a signal indicating that humidity or a level thereof is present in the chamber may be automatic, such as via a controller or the like, or the flow of fluid from the chamber of the fluid collector. It may only provide an indication that there is a level of humidity that may require removal. In the latter case, the user can receive the indication and activate the vacuum pump.

In one example, the method 500 can include collecting fluid removed from the fluid collection device, eg, in a fluid reservoir spaced apart from the fluid collection device and fluidly coupled to the conduit. The fluid reservoir can include any of the fluid reservoirs disclosed herein.

FIG. 6 is a flow diagram of a method 600 for making a fluid collection device, according to one embodiment. Method 600 may include an operation 610, which describes "providing wicking material." Operation 610 may be followed by operation 620, which is "coating the wicking material with a fluid impermeable coating to form a coated wicking material having an opening therein." describe. Action 620 may be followed by action 603, and action 630 describes "disposing a conduit in the coated wicking material to form a fluid collector."

Operations 610, 620, and 630 of method 600 are for illustrative purposes. For example, operations 610, 620, and 630 of method 600 may be performed in different orders, split into multiple operations, modified, supplemented, or combined. In one example, one or more of operations 610 , 620 , and 630 of method 600 may be omitted from method 600 . For example, method 600 may not include operation 630 . Any of operations 610, 620, or 630 may involve using any of the fluid collection devices, vacuum sources, fluid reservoirs, systems, or components thereof disclosed herein. For example, the fluid impermeable coating at least partially defines a chamber, an opening extending therethrough, the opening being positioned adjacent to the female urethra or positioned through the male urethra. sized and shaped to A fluid collector formed by method 600 may include any of the fluid collectors disclosed herein. For example, the fluid collection device can include a wicking material disposed with the chamber and a conduit disposed within the wicking material, the conduit including an inlet and an outlet disposed within the fluid collection device.

Method 610 describes "providing wicking material." Providing the wicking material can include providing any of the wicking materials in any of the configurations disclosed herein. For example, providing a wicking material can include providing a cylindrical wicking material, eg, one or more of a cylindrical fluid permeable membrane or fluid permeable support. Providing the wicking material may include providing the wicking material of any of the female fluid collection devices disclosed herein. For example, the fluid permeable support can be arranged concentrically with the fluid permeable membrane. The fluid permeable support may include channels formed therethrough to accommodate the conduits.

Providing wicking material may include providing wicking material for any male fluid collection device disclosed herein. For example, providing a wicking material can include providing a fluid permeable membrane concentrically disposed within a fluid permeable support. The fluid permeable support and fluid permeable membrane can have channels formed therein to allow the insertion of conduits therein.

Operation 620 describes "coating a wicking material with a fluid impermeable coating to form a coated wicking material having an opening therein." Coating the wicking material with a fluid impermeable coating to form a coated wicking material having openings therein includes coating or impregnating the outer surface of the wicking material with the fluid impermeable coating material. forming openings in the fluid impermeable coating. The openings can be as described herein for the female fluid collection device or the male fluid collection device.

Coating the wicking material with a fluid-impermeable coating to form a coated wicking material having openings therein can be performed using any of the thickness, surface properties, or shapes disclosed herein. any of the fluid impermeable coating materials disclosed herein. Coating the wicking material with a fluid impermeable coating to form a coated wicking material having openings therein can be performed by dipping (e.g., dip coating), spraying (e.g., spray coating), packaging (eg, shrink wrapping), brushing, rolling, casting, impregnating (eg, vacuum infiltration), and the like. For example, the opening may be formed by masking a portion of the wicking material with a masking agent and dip coating the wicking material (and optionally the first and second end caps) with a fluid impermeable coating material. can be formed. After the fluid impermeable coating material dries, the masking agent may be removed from the wicking material to reveal the openings. In some examples, coating the wicking material with a fluid impermeable coating to form a coated wicking material having openings therein selected with a fluid impermeable coating It may involve coating only the portion of the wicking material (or end cap) outside the selected size and location of the opening. Thus, selective application of fluid impermeable coating materials can be used to form the openings.

Operation 630 describes "disposing a conduit in the coated wicking material to form a fluid collector." Placing the conduit in the coated wicking material to form the fluid collection device may include inserting the conduit a distance into the coated wicking material. For example, a conduit may be threaded through the wicking material and inserted into a reservoir within the chamber of the fluid collector. In some examples, placing the conduit in the coated wicking material wicks the conduit to a point within the wicking material or until the inlet of the conduit is coextensive with the wicking material. It can include disposing in a material. Placing the conduit in the coated wicking material may include inserting the conduit through the coating.

Placing the conduit in the coated wicking material to form the fluid collection device converts the conduit to any of the fluid collection devices disclosed herein, such as the female fluid collection device or the male fluid collection device. It may include placing in a wicking material coated enough to form the device.

In some examples, prior to coating, method 600 includes placing end caps on one or more ends of the wicking material, e.g., any of the end caps or caps disclosed herein. placing on either end of the coated wicking material to be coated. For example, method 600 can include placing end caps on each end of a fluid permeable membrane disposed on a cylindrical fluid permeable support. Placing the end cap on the second end of the coated wicking material can form a reservoir in the chamber, eg, between the end cap and the wicking material. In such instances, the coating may be placed over or under the end cap or caps. In some examples, placing end caps on one or more ends of the wicking material may be performed after coating at least a portion of the wicking material with a coating. In some examples, placing the end caps on one or more ends of the wicking material may include adhering the end caps to one or more of the wicking material or the fluid impermeable coating.

In some examples, method 600 may include connecting a conduit of the fluid collection device to a vacuum source, either indirectly or directly. For example, connecting the conduit of the fluid collection device to the vacuum source may include connecting the conduit to the fluid reservoir. Connecting the conduit of the fluid collection device to the vacuum source can include forming any of the systems disclosed herein.

As used herein, the terms "about" or "substantially" refer to acceptable variations of the term modified by "about" to ±10% or ±5%. Further, the terms “less than,” “less than,” “greater than,” “greater than,” or “greater than” may be used as endpoints. ”, or values modified by the terms “greater than or equal to”.

While various aspects and embodiments are disclosed herein, further aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.

Claims (27)

at least one wicking material including an outer surface;
a fluid impermeable coating adhered to at least a portion of the outer surface of the at least one wicking material defining a chamber within a fluid collection device partially enclosing the at least one wicking material; defining an opening through which a portion of said at least one wicking material is exposed, said opening being configured to be positioned adjacent to a female urethra or through which a male urethra is positioned. a fluid impermeable coating;
Fluid collector. 3. The fluid collection device of claim 1, wherein the at least one wicking material comprises one or more of a fluid permeable membrane or a fluid permeable support. 3. A fluid collection device according to claim 1 or 2, wherein the fluid impermeable coating is adhered to the outermost portion of the fluid permeable membrane. 3. A fluid collection device according to claim 1 or 2, wherein the fluid impermeable coating is embedded within the outermost portion of the fluid permeable membrane. A fluid collection device according to any preceding claim, wherein the fluid impermeable coating comprises one or more of polymers, waxes, nanocelluloses or nanoparticles. A fluid collection device according to any preceding claim, wherein the fluid impermeable coating comprises a superhydrophobic material. A fluid collection device according to any preceding claim, wherein the fluid collection device is configured as a female fluid collection device. A fluid collection device according to any preceding claim, wherein the fluid collection device is configured as a male fluid collection device. A fluid collection device according to any preceding claim, wherein the fluid collection device is substantially cylindrical. A fluid collection device according to any preceding claim, wherein the at least one wicking material is arranged in a substantially cylindrical configuration. a first end cap positioned over a first end of said cylindrical configuration and a second end cap positioned over a second end of said cylindrical configuration; 11. The fluid collection device of claim 10, further comprising, wherein said first end cap and said second end cap retain said wicking material in said cylindrical configuration. 12. The fluid collection device of claim 11, wherein the fluid impermeable coating is disposed over a portion of the wicking material, the first end cap and the second end cap. The apparatus of claims 1-12, further comprising a conduit disposed within the chamber, the conduit including an inlet disposed within the chamber and an outlet configured to be fluidly coupled to a vacuum source. A fluid collection device according to any one of the preceding paragraphs. a fluid reservoir configured to hold a fluid;
A fluid collection device comprising:
at least one wicking material including an outer surface;
a fluid impermeable coating adhered to at least a portion of the outer surface of the at least one wicking material defining a chamber within a fluid collection device and a portion of the at least one wicking material exposed; a fluid-impermeable coating defining an opening and configured such that the opening is positioned adjacent to the female urethra and through which the male urethra is positioned;
a fluid collection device including a conduit disposed within the chamber, the conduit including an inlet disposed within the chamber and an outlet configured to be fluidly coupled to a vacuum source; ,
a vacuum source fluidly coupled to one or more of the fluid reservoir or the outlet of the fluid collection device, the vacuum source configured to draw fluid from the fluid collection device;
Fluid collection system. 15. The fluid collection system of claim 14, wherein the at least one wicking material comprises one or more of a fluid permeable membrane or a fluid permeable support. 16. The fluid collection system of claim 15, wherein the fluid impermeable coating is adhered to the outermost portion of the fluid permeable membrane. 17. The fluid collection system of claim 15 or 16, wherein the fluid impermeable coating is embedded within the outermost portion of the fluid permeable membrane. 18. The fluid collection system of any one of claims 14-17, wherein the fluid impermeable coating comprises one or more of polymers, waxes, nanocelluloses, or nanoparticles. The fluid collection system of any one of claims 14-18, wherein the fluid impermeable coating comprises a superhydrophobic material. The fluid collection system of any one of claims 14-19, wherein the fluid collection device is configured as a female fluid collection device. The fluid collection system of any one of claims 14-19, wherein the fluid collection device is configured as a male fluid collection device. The fluid collection system of any one of claims 14-21, wherein the at least one wicking material is arranged in a substantially cylindrical configuration. a first end cap positioned over a first end of said cylindrical configuration and a second end cap positioned over a second end of said cylindrical configuration; 23. The fluid collection system of claim 22, further comprising, wherein said first end cap and said second end cap retain said wicking material in said cylindrical configuration. 24. The fluid collection system of claim 23, wherein the fluid impermeable coating is disposed over a portion of the wicking material, the first end cap and the second end cap. A method of collecting a fluid comprising:
locating an opening of a fluid collection device adjacent to or about a user's female urethra, said opening being defined by a fluid impermeable coating of said fluid collection device; and
receiving fluid from the female urethra or the male urethra into a chamber of the fluid collection device, the chamber of the fluid collection device being at least partially defined by the fluid impermeable coating. include,
Method. Claim 25, further comprising applying suction by a vacuum source effective to draw said fluid from said chamber via a conduit disposed within said chamber and fluidly coupled to said vacuum source. The method described in . Applying suction by a vacuum source effective to draw the fluid from the chamber via a conduit disposed within the chamber and fluidly coupled to the vacuum source removes at least some of the fluid from the chamber. from the chamber of the fluid collection device to a fluid reservoir operably coupled thereto.

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